CMS amends restriction of only one FDG PET scan for certain tumors

FDG-PET/CT image depicting liver metastases in a patient with inflammatory breast cancer. Image source: RSNA (Carkaci et al)

The Centers for Medicare & Medicaid Services (CMS) has issued a decision memo stating that the national coverage determination (NCD) manual will be changed to remove the current absolute restriction of coverage to ‘only one’ FDG PET scan, and local Medicare administrative contractors will have discretion to cover (or not cover) any additional FDG PET scan for initial treatment strategy in solid tumors and myeloma.

After a review, CMS said that it believed that the current absolute restriction is not supported by the available evidence, and therefore will amend 220.6.17 of the NCD manual:

1. The NCD manual will be changed to remove the current absolute restriction of coverage to ‘only one’ FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy;
2. CMS will continue to nationally cover one FDG PET scan to determine the location and/or extent of the tumor for the therapeutic purposes related to the initial treatment strategy; and
3. Local Medicare administrative contractors will have discretion to cover (or not cover) within their jurisdictions any additional FDG PET scan for the therapeutic purposes related to the initial treatment strategy.

“For any individual beneficiary the usefulness of any additional FDG PET scan for initial treatment planning might be affected by the beneficiary’s specific medical problem, the availability of results of other diagnostic tests and the expertise of the interpreting physician,” stated CMS in the memo. In such situations, the agency said their local administrative contractors, who may more readily obtain this information, can make these determinations about any additional FDG PET scan for initial treatment planning within their jurisdictions.

The section 220.6.17 of the NCD manual previously described, that established an absolute frequency limitation of only one FDG PET study for the noted purposes. The agency wrote it will cover 'only one' FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

CMS received 35 public comments during the initial comment period from Nov. 9, 2009 through Dec. 9, 2009 and four comments pertaining to this decision from May 6 through June 5.